Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Jun 2011
21 CFR 120.11(a)(1)(iv)
Verification - CCP, CA record review
Cited by Rocio Guzman-Velazquez
9 Jun 2011
21 CFR 120.12(b)
Records - general - include name, date, time
Cited by Rocio Guzman-Velazquez
Inspected site
TTTree Top, Inc.Oxnard, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 120.11(a)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere